Grandma's Herbs, Inc. – FDA Warning Letter

The FDA reviewed Grandma's Herbs, Inc.'s website in July 2017 and determined that numerous products, including "Anti-Plague Formula," "Aspire," and "Vitality," are marketed with claims that establish them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). These products are intended for the cure, mitigation, treatment, or prevention of disease, making their introduction into interstate commerce illegal without prior FDA approval.

Specific claims cited include "Anti-Plague Formula" for colds, flu, and plagues; "Aspire" for respiratory conditions like pneumonia and asthma; "Cayenne" for healing ulcers and stopping internal bleeding; and "Vitality" for arthritis, hemorrhoids, and preventing stroke.

Furthermore, several products, such as "Aspire," "Cayenne," and "Prostate," are deemed misbranded under section 502(f)(1) of the Act because they are intended for conditions not amenable to self-diagnosis or treatment, thus lacking adequate directions for layperson use.

Grandma's Herbs, Inc. must take prompt action to correct these violations. Failure to do so may result in enforcement actions, including seizure and/or injunction. The company is required to respond in writing within fifteen working days, detailing corrective steps and a timeline for completion.